You scratch my back, I’ll scratch yours. Favors are often exchanged among friends and family. But what most people don’t know, or don’t want to know, is that questionable “favors” are also exchanged in professional and business relationships. Over the years, there have been reports that favors, or benefits, are too often exchanged between drug manufacturers and doctors and hospitals who prescribe medicines.

Recent studies have explored this relationship and compared data to see if drug makers are, effectively, paying doctors to prescribe their medications.

In 2010, the Affordable Care Act included a section called the Physician Payment Sunshine Act. This Act requires drug and device manufacturers to report any and all payments made to physicians and hospitals. Since 2013, 40.74 million records have been published and $24.92 billion dollars have been given to doctors and hospitals from drug and device manufacturers. The Sunshine Act has been successful at exposing these payments.

Open Payments is a website that provides a listing of doctors who receive money or incentives from drug manufacturers. The website is very easy to use; you can visit the website and simply type the name of a doctor or hospital in the search bar and see if they are receiving money – how much, from whom, and when.

Recently, UNC-Chapel Hill conducted a study to determine if there was a correlation between the amount of money doctors received from drug companies and the frequency with which doctors prescribe that company’s drugs. Put another way – are doctors more likely to prescribe a company’s drug if that company is giving them money?

The study used information and data from the Open Payments website as well as from the Centers for Medicare & Medicaid Services to answer that question. Turns out, the answer is “yes.” Focusing specifically on cancer doctors, the research study found that there are “increased odds of prescribing a manufacturer’s drug among physicians receiving payments.”

Unfortunately, this study is not the first of its kind. Research has shown this correlation, an increased likelihood of prescribing a company’s medicine if that company pays the doctor or hospital, for many different types of medications.

For example, in 2016, a similar study was performed, this time focusing on cholesterol medicines. The same conclusion was made – manufacturer payments to doctors and hospitals correspond with higher rates of prescribing that manufacturer’s cholesterol medicine.

While all medicines are supposed to help patients, there is a potential concern that doctors might not be prescribing a medicine that is best for the patient, but rather prescribing a medicine that is best for their bank account.

If you are wondering if your doctor is receiving payments for prescribing specific drugs, ask your doctor or go to the Open Payments website. As I always advise, it is important to do your homework on your doctor, your medications, your medical devices, everything related to your health. (Of course, you should also do your homework on your choice of attorney as well.) If you would like to discuss any prescription medication that gives you concern, give me a call and we can sort it out.

According to the American Society of Plastic Surgeons almost 280,000 breast augmentation procedures took place in the United States in 2015. Given the popularity of breast implants, a wide range of breast implant products have been released in the United States and the rest of the world. One such product is the textured breast implant.

Why Are Breast Implants Textured?

The purpose of adding texturing to the breast implant surface is to help the body keep the implant in place and avoid it from shifting. Another reason is to prevent a complication called capsular contracture, which occurs when the scar tissue that forms around the implant become painful and hard.

Despite these logical reasons for using textured breast implants, the Food and Drug Administration (FDA) has concluded there is a clear link between textured breast implants and Anaplastic Large Cell Lymphoma.

What is Anaplastic Large Cell Lymphoma?

Anaplastic Large Cell Lymphoma, or ALCL, is a rare type of non-Hodgkin’s lymphoma, or cancer of the blood. In ALCL, the white blood cells grow uncontrollably and can spread to the lymph nodes and skin, in addition to the breast itself. ALCL is not breast cancer and if found early it can be effectively treated, although it can be fatal if not treated soon enough.

One of the common forms of treatment involves removing the breast implant along with the scar tissue capsule surrounding it in a procedure called capsulectomy. About 70% of the time, this is the only treatment needed to be cured of ALCL, although radiation and chemotherapy may also be required.

Common symptoms of ALCL include:

• Ongoing pain in the area surrounding the breast implant (this is the most common symptom)
• Fluid buildup, lumps or hardening masses surrounding the breast implant
• Fever
• Backache
• Fatigue
• Swelling of the lymph nodes

The Connection Between Textured Breast Implants and ALCL

In 2011, the FDA noted a possible connection between textured breast implants and ALCL. However, in March of this year, the FDA officially recognized the link between textured breast implants and ALCL.

Of the 231 medical device reports the FDA received where individuals who had ALCL also indicated the type of breast implant they received, 203 of the ALCL patients had textured breast implants while only 28 had smooth surface breast implants. This is a troubling statistic, and more study is needed.

Ideally, more data would be available for analysis, but unfortunately, it’s been somewhat sparse. For example, even though there were 231 ALCL medical device reports the FDA received identifying the breast implant type, 128 of the reports made no mention of the breast implant surface type. Currently, there is no comprehensive database of breast implant recipients and ALCL sufferers although efforts are being made to create one. It is critical that we get more information.

How Does the Textured Surface Cause ALCL?

This is likely the multi-billion dollar question because right now, no one seems to know for sure why textured breast implants result in a much higher rate of ALCL.

One reason for this lack of clarity is that multiple companies offer textured breast implants and the implants have different types of texturing and there are different ways of manufacturing the textured surface. However, there is one predominant theory to explain the link between a textured surface and ALCL.

This explanation is that ALCL is caused by a bacterial infection in the textured surface that starts an inflammatory response in the body. It has been established that certain types of lymphoma can be caused by chronic infections.

Does This Mean I Can Sue if I Have a Textured Breast Implant?

We are still early in the process. The FDA recognized the link just a few months ago. But if you suffer from ALCL after getting textured breast implants, it’s important (1) to get medical treatment immediately and (2) to keep detailed records of your pain, your medical care, medical bills, and any other vital information relating to your ALCL.

These companies manufacture textured breast implants, and it is important for them to study the issue immediately and thoroughly as we move forward:

• Allergan
• Sientra
• Mentor
• Ideal Implant, Inc.

So What Now?

Basically, we wait-and-see. The FDA does not recommend patients have their breast implants removed unless they have symptoms of ALCL or other adverse reactions to the textured breast implants. If you suffer any problems with your textured breast implants, you should see your doctor as soon as you can.

I will update this information as I receive more news, so keep checking back with me.

As if erectile dysfunction were not harrowing enough. In March 2016 a published study concluded that the use of the drug sildenafil (Viagra), vardenafil (Levitra), and tadalafil (Cialis) “could promote melanoma in humans.”

As you probably know, melanoma is the most aggressive and most dangerous form of skin cancer. Melanoma develops when damage to skin cells (usually caused by ultraviolet radiation from sunshine or tanning beds) triggers mutations that lead the skin cells to multiply rapidly and form malignant tumors. Most people think of melanoma as dark, asymmetrical moles, and in fact melanoma can develop from existing moles, but melanoma can also form directly on the skin. Melanoma is often caused by intense, sustained exposure to ultraviolet light, the kind which causes suntans and sunburns. Melanoma has been estimated to cause over 10,000 deaths in the United States each year.

The Latest Study

A team of researchers recently published findings from a study of the potential connection between the increased risk of melanoma in humans who take erectile dysfunction drugs like Viagra. The study is titled Sildenafil Potentiates a cGMP-Dependent Pathway to Promote Melanoma Growth, which you can access here. This study identified a pathway in the cells of the human body which can permit the growth of melanoma. The science behind the study is complex and technical, but let’s give it try:

Sildenafil (Viagra) is a phosphodiesterase 5 inhibitor (PDE5). When PDE5 is inhibited, a man has the enhanced ability to gain an erection. And that’s a good thing. Unfortunately, according to the study, the inhibition of PDE5 in the human body also increases the level of “cyclic guanosine-3′, 5′-monophosphate” (cGMP), which is described as “a signaling molecule,” and increased levels of cGMP in the body promotes “mitogen-activated protein kinase” (MAPK), which is a pathway in the molecules associated with the increased growth of melanoma cells. When PDE5 is not inhibited, there are low cGMP levels and less active melanoma growth. But when sildenafil or other drugs inhibit PDE5, it causes a molecular reaction which promotes the malignant growth of melanoma cells. So the inhibition of PDE5 increases cGMP levels, which promotes MAPK, which encourages melanoma cell growth. Got it?

Vardenafil (Levitra) and tadalafil (Cialis) are also PDE5 inhibitors. The study states that Levitra and Cialis would also operate like Viagra to promote melanoma cell growth through similar molecular reactions.

Other studies have linked the use of Viagra to an increased risk of melanoma, including one from the Journal of American Medical Association (JAMA) in 2014.

Viagra Maker Denies Increased Melanoma Risk

Pfizer is the manufacturer of Viagra, the first and most popular of the drugs used to treat erectile dysfunction. Pfizer has denied any increased melanoma risk, stating that Viagra has been studied in 136 clinical trials and that “there is no reliable scientific evidence that the medicine causes melanoma.” It is important to listen to the denial, as Pfizer states there is no reliable scientific evidence, which recognizes that there is scientific evidence; Pfizer thus discounts the existing scientific evidence as “unreliable.” Pfizer has stated that it stands behind “this important medicine” and intends to “vigorously defend these lawsuits.”

I also read one article which suggested that the Viagra lifestyle was the cause of the increased incidence of melanoma (and not the Viagra itself). The “Viagra lifestyle” was suggested to be a world where men would take their romantic partners to places like the Caribbean or on a boat, places where exposure to the sun’s damaging rays was higher. I would advise skepticism for this theory. I have not seen any evidence that men who use Viagra had better sun tans than those men who did not take Viagra, except on all the commercials.

The Lawsuits Are Mounting

In April, the U.S. Judicial Panel on Multidistrict Litigation created a MDL site in the Northern District of California for lawsuits from those alleging injury against Pfizer from the use of Viagra. Judge Richard Seeborg of San Francisco has been assigned to preside over the Viagra MDL. The central allegations are that (1) sildenafil increases the risk of developing melanoma and that (2) Pfizer failed to warn consumers and medical care providers of the risk. Originally fourteen cases were transferred to the Viagra MDL, but more are being filed each week.

Pfizer first sold Viagra in 1998. And to no one’s surprise, it became hugely popular and very profitable. In 2013 alone Pfizer made $1.8 billion dollars from the sale of Viagra worldwide. All this to say that many millions of men have taken Viagra over the past eighteen years. If the studies are accurate, this is an army of men more vulnerable to the onset of life-threatening skin cancers.

The Takeaway

Let’s face it, compromised conditions of aging, like bad knees or erectile dysfunction, can dramatically reduce a person’s quality of life. For years medications like Viagra seemed like a great way to extend an aging man’s ability to engage in sexual intercourse (which is a great thing to engage in). However, the most recent study of Viagra, coming as it does after other studies concluding that Viagra may increase the risk of melanoma, suggests that the use of erectile dysfunction drugs may not be worth it. Talk at length to your doctor about the risks of taking Viagra or Levitra or Cialis. Of course avoid excessive sun exposure and always wear sunscreen. Above all, keep a careful watch about any news reports of new studies linking Viagra and similar drugs to the onset of melanoma.

Over the years I have worked with many people who had hip replacement surgery. Many of these clients discovered high metal levels in their bodies from metal-on-metal (MoM) hip components. Often the person would let me know that she had her metal levels checked and that the blood work came back with abnormally high readings of cobalt, chromium, or other metals. Still, the treating physician would occasionally dismiss the blood work results. At least one doctor told a patient, “no one knows the effects of higher metal levels on the body. We haven’t studied the impact of metallosis sufficiently. It is nothing to be worried about at this point.”

Sadly, this isn’t true. And it’s not the best medical advice. There have been several studies over the years that looked at metallosis in the body derived from metal-on-metal hip components. The first incident of metallosis from MoM hip implants was reported in 1971. Since then, doctors have been reporting the higher incidence of metallosis in patients who received MoM artificial hip implants. Several scholarly studies have been conducted, including a recent one whose results were published this month examining the impact of metallosis on the cells of patients.

What Is Metallosis?

Metallosis is a serious medical condition involving the deposit and build-up of metal debris in the soft tissues of the body. Metallosis has been shown to occur when metal components in medical implants rub or scrape against each other. Imagine the metal cup and the metal ball in an artificial hip grinding against each other day after day, for months and years. Very tiny metal shavings can be scraped away and released into the human body. Over time, these tiny shavings can build up alarming metal levels in the blood. It is common in hip replacements but also occurs in other joint replacements.

The Latest Study on Metallosis

In the August 2016 edition of Biomaterials, an international research team looked at the physical impact of metallosis on the body. They studied metal-on-metal hip components made of cobalt and chromium and/or molybdenum alloys (CoCrMo). The study confirmed that use of these hip components can lead to the “release of wear products such as metallic particles and dissociated metal species, raising concerns regarding their safety” for orthopedic surgeons and patients. The study showed that release of these metal particles in the body are capable of producing problems on a cellular level, and can cause “aseptic osteolysis” and other health problems. Osteolysis is the destruction or disappearance of bone tissue.

The study also examined the impact of metallosis on “mesenchymal stromal cells.” These are multi-functional cells that can develop into several different cell types which produce bone, cartilage, muscle or fat. According to the study, metallosis interferes with this cell development and can cause serious problems and “impair osteogenic differentiation of MSCs.” That’s a mouthful, but it’s not good.

Importantly, the study concluded by saying that the continued use of cobalt, chromium, and molybdenum alloys for joint replacement implants “needs critical reconsideration.”

Dr. James Pritchett is an orthopedic surgeon who writes a lot about the onset of metallosis following hip implants. He states that symptoms of metallosis include pain, instability, and increasing noise from the hip. In addition, metallosis may cause some or all of these symptoms: pseudo-tumors, nerve and thyroid problems, brain impairment, heart problems, depression and anxiety, visual impairment, rashes, infection, and implant loosening.

The Takeaway

The takeaway is that more and more studies are showing that high metal levels in the blood are a bad thing. The recent study in Biomaterials journal points to harmful changes that metal levels can cause to the cells of human tissue, and that use of metal-on-metal components for artificial hips and other joints must be “reconsidered.” I hear that to mean: “discontinued immediately.” In any event, do not accept your physician’s offhand comment that your higher metal levels (even if only slightly higher than normal) are of no concern. Get a second opinion. Metallosis is not a healthy condition. Good luck.

Note: This post does not reference any individual person or client. The information is general and is derived from many circumstances over several years.

For further information, check out the Biomaterials website. Biomaterials is an international journal covering the science and clinical application of biomaterials. But be warned: these are people with high levels of very specific knowledge. Pack a medical dictionary.

People who get medical implants don’t do so out of boredom. They get the surgery because they have a serious medical problem or they want to prevent one. Many of these implants have benefits for patients while some, in addition to doing some good, also can do great harm. The Cook IVC filter may be a medical implant that not only may do you no good but can also do great harm, according to a recent study published in the medical journal Annals of Surgery.

What is a Cook IVC filter?

The Cook IVC filter is a wire device that looks like a cone shaped net. It is manufactured by Cook Group, Inc. The IVC filters are surgically inserted into a major vein, the inferior vena cava (IVC), of a patient who is at risk for a pulmonary embolism (or PE, a blood clot that passes into a lung, which can be fatal). The filter is supposed to trap or break up blood clots coming from the lower or middle part of the body. On first look it appears to be a great idea. But many medical emergencies have resulted from implantation of these IVC filters.

Hundreds of lawsuits have been filed by those injured by Cook IVC filters and by the families of people who died because of them. The filters are often in patients too long; they can break up (with pieces going into the heart or lungs) or the entire filter can be pushed up near or into the heart, causing death or injuries.

more Study finds no upside to using IVC filters but does find a down side

Often physicians will use a Cook IVC filter after a patient has suffered an accident or some kind of trauma fearing a blood clot may form and move into the heart or lungs. Researchers did the study to see if they could establish a benefit for trauma patients treated with implantation of IVC filters.

After looking at the records of 803 patients from 2010 to 2014 who had an IVC filter implanted in them after a traumatic event, those conducting the study not only found no benefit but also an increased risk of injury. The survival rates of patients with IVC filters implanted to prevent potential injuries were no better than those without them. In addition to this lack of benefit they found use of the filters resulted in an increased chance of getting deep vein thrombosis.

• Deep vein thrombosis (DVT) is the term for when a blood clot forms in a vein deep in the body.
• This condition occurs in the lower leg or thigh most often but may occur in other parts of the body as well.
• One of the dangers of DVT is that the clot may break off and move through the bloodstream possibly ending up in the heart or lungs.

The purpose of the study was to see if IVC filters prevented health problems, so those already diagnosed with DVT or PE were not made part of the study. Further, the use of the filters varied widely depending on which hospital treated the patient. In some areas the local doctors inserted them at a much higher rate than others.

What the study means for doctors, patients, and lawsuits

Use of any kind of medical implant involves weighing the costs and benefits for the patient. Given this study,

• There was no benefit for those who were injured in an accident to use an IVC filter to prevent possible future blood clots from moving into the heart or lungs. That is to say, there was no evidence that the patient will live a shorter life without one, but
• There are risks (an increased risk of DVT along with the dangers posed by a defective filter breaking up and causing harm).

In legal proceedings this kind of information may also be helpful to show those involved in the manufacture and sale of Cook IVC filters (and other IVC filters) may have acted negligently and should pay damages to those harmed by the device. Without any measurable benefit to the patient, exposing that patient to a known risk would be evidence of negligence.